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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
About Reliance Orthodontic Products, Inc.:
Reliance Orthodontics is a Global Dental company in the Western suburbs of Chicago that specializes in Orthodontic adhesives. We have been a family owned leading supplier in a field consumed by corporate giants for over 30 years. Our small business roots give us the ability to be dynamic, accommodating and responsive. Our staff of 30 employees have an ...average tenure of 12 years due to flexible work schedule options and a genuine appreciation for their efforts.
We are currently seeking a Regulatory or Quality Specialist to support activities related to ISO 13485, EU Medical Device Directive, Health Canada, US FDA 21 CFR and other global regulations. This position will be responsible for helping maintain quality system and compliance for our Orthodontic device product lines with appropriate supervision. They will be responsible for creation of high-quality regulatory and quality documentation for new and existing products including design control and compliance activities per established quality system.